A Phase 1, Randomized, Two-part, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity and Pharmacodynamics of LAD106 in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Part B (MAD): Number of Participants with TEAEs and Severity of TEAEs
研究概览
简要总结
The main aim of this study is to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity and pharmacodynamics (PD) of single ascending doses of LAD106 (Part A) and multiple ascending doses of LAD106 (Part B) in human healthy participants.
详细描述
This is a 2-part study. Part A will comprise up to 6 cohorts of healthy adult participants and investigate single ascending doses of LAD106. Part B will comprise up to 3 cohorts of healthy adult participants to evaluate multiple ascending doses of LAD106, and 1 cohort will investigate the pharmacodynamic effects of lebrikizumab. The study is based on sequential cohorts for escalation of single and multiple doses of LAD106, where progression to the next cohort is only started following a review of safety, tolerability, and pharmacokinetic data of earlier study cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent and willing and able to comply with the study protocol.
- •Healthy men or women,18 to 45 years of age (inclusive) at screening.
- •Female participants agree to use effective contraception.
- •Male volunteers agree to use barrier protection when they engage in sexual relations with women of child-bearing potential (WOCBP) or lactating women.
- •Body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m^2), inclusive, and with a minimum bodyweight of 50 kg.
- •Has the ability to communicate well with the Investigator in Dutch language and willing to comply with the study restrictions.
排除标准
- •Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the participant in the opinion of the investigator.
- •Clinically significant abnormalities, as judged by the Investigator, in laboratory test results.
- •Use of any medications (prescription or over-the-counter [OTC]), within 14 days prior to IMP dosing or less than 5 half-lives (whichever is longer). An exception is made for paracetamol (up to 4 g/day).
- •If a woman, pregnant, or breast-feeding, or planning to become pregnant during the study.
研究组 & 干预措施
Part A: LAD106 (Cohort 4)
Participants will receive a single ascending dose of LAD106 (Dose 4).
干预措施: LAD106 (Drug)
Part A: LAD106 (Cohort 5)
Participants will receive a single ascending dose of LAD106 (Dose 5).
干预措施: LAD106 (Drug)
Part A: LAD106 (Cohort 6)
Participants will receive a single ascending dose of LAD106 (Dose 6).
干预措施: LAD106 (Drug)
Part A: Placebo
Participants will receive a single dose of placebo matching LAD106.
干预措施: Placebo (Other)
Part B: LAD106 (Cohort A)
Participants will receive a multiple ascending dose of LAD106 (Dose 1).
干预措施: LAD106 (Drug)
Part A: LAD106 (Cohort 1)
Participants will receive a single ascending dose of LAD106 (Dose 1).
干预措施: LAD106 (Drug)
Part A: LAD106 (Cohort 2)
Participants will receive a single ascending dose of LAD106 (Dose 2).
干预措施: LAD106 (Drug)
Part A: LAD106 (Cohort 3)
Participants will receive a single ascending dose of LAD106 (Dose 3).
干预措施: LAD106 (Drug)
Part B: LAD106 (Cohort B)
Participants will receive a multiple ascending dose of LAD106 (Dose 2).
干预措施: LAD106 (Drug)
Part B: LAD106 (Cohort C)
Participants will receive a multiple ascending dose of LAD106 (Dose 3).
干预措施: LAD106 (Drug)
Part B: Placebo
Participants will receive a multiple dose of placebo matching LAD106.
干预措施: Placebo (Other)
Part B: Lebrikizumab (Cohort 0)
Participants will receive lebrikizumab.
干预措施: Lebrikizumab (Drug)
结局指标
主要结局
Part B (MAD): Number of Participants with TEAEs and Severity of TEAEs
时间窗: From start of study drug up to follow-up (Day 104)
Part A (SAD): Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Severity of TEAEs
时间窗: From start of study drug up to follow-up (Day 81)
次要结局
- Part A (SAD) and B (MAD): LAD106 Serum Concentrations Over Time(Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD)
- Part A (SAD) and B (MAD): Maximum Serum Concentration (Cmax) of LAD106(Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD)
- Part A (SAD) and B (MAD): Time to Reach Maximum Serum Concentration (tmax) of LAD106(Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD)
- Part A (SAD) and B (MAD): Area Under the Serum Concentration-time Curve (AUC) of LAD106(Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD)
- Part A (SAD) and B (MAD): Elimination Half-life (t½) of LAD106(Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD)
- Part A (SAD): Absolute Bioavailability of LAD106(Up to Day 78)
- Part A (SAD) and B (MAD): Number of Participants with Anti-drug Antibodies (ADA) Positive Samples(Pre-dose up to Day 78 for SAD and up to Day 99 for MAD)
- Part A (SAD) and B (MAD): Titer of Confirmed ADA Positive Samples(Pre-dose up to Day 78 for SAD and up to Day 99 for MAD)